Lately there is an increased interest in finding disease bio-markers in human body fluids such as blood plasma, urine, CSF and also oral fluids. Oral fluids can be easily and non-invasively collected with low collection, storage and shipment costs, and thus allow vast epidemiologic screening. One main drawback in oral fluid protein identification is the very high relative amount of α-Amylase protein (comprising up to 60% of saliva proteins, the major component of oral fluids) which masks the presence of other protein components.
The α-amylases (EC 3.2.1.1, CAS#9014-71-5, alternate names: 1,4-α-D-glucan glucanohydrolase; glycogenase) are calcium metalloenzymes, completely unable to function in the absence of calcium. By acting at random locations along the starch chain, α-amylase breaks down long-chain carbohydrates, ultimately yielding maltotriose and maltoe from amylose, or maltose, glucose and “limit dextrin” from amylopectin. Because it can act anywhere on the substrate, α-amylase tends to be faster acting than β-amylase. In animals, it is a major digestive enzyme.
U.S. Pat. No. 5,576,181 to Torrens et al., is aimed at reducing the amount of amylase by using monoclonal antibodies against salivary amylase for the purpose of detecting remaining pancreatic amylase activity. However, this method is of low practical utility since antibodies are expensive and difficult to store in a stable manner for long periods of time; consequently, this method has not gained wide acceptance.
Therefore there is a need for cost effective means for removing amylase from body fluids, in particular, oral fluids.
It is an object of the present invention to provide an assay, kit, device and method, for efficiently removing amylase from body fluids.
It is another object of the present invention to provide methods and devices for minimizing, or preventing, screening effects caused by α-amylases protein in the laboratory assay of oral fluids.
It is a further object of the present invention to provide an assay, kit, device and method, for collecting amylase from oral fluids.
Other objects and advantages of the invention will become apparent as the description proceeds.